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Dockets Management
Dockets Entered On March 15, 2004
Table of Contents
Docket # Title
1978N-0064 OTC Antiperspirant
1991N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements
1991N-0100H Health Claims & Label Statements; Folate & Neural Tube Defec
1991N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement
1991N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements
1992N-0489 Taxol; Enviromental Assessments and Fonsi
1993N-0480A Health Claims for Antioxidant Vitamins & Cancer
1993N-0480C Health Claims for Dietary Fiber & CVD
1993N-0480F Health Claims for Dietary Fiber & Cancer
1995N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
1999P-2630 Establish a Daily Value for "added sugars"
2000P-1322 Food Labeling and Allergen Contamination Control
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002N-0204 Bar Code Label Requirements for human drug products
2002N-0417 Applications for FDA Approval to Market a New Drug
2003D-0493 Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0496 Food Labeling: Health Claims; Dietary Guidance
1978N-0064 OTC Antiperspirant
SUP 5 Revlon, Inc. Vol #: 51
1991N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements
MT 1 HFS-832 to Emord & Associates, PC Vol #: 1
1991N-0100H Health Claims & Label Statements; Folate & Neural Tube Defec
MT 1 HFS-832 to Emord & Associates, PC Vol #: 16
1991N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement
MT 1 HFS-832 to Emord & Associates, PC Vol #: 46
1991N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements
MT 1 HFS-832 to Emord & Associates, PC Vol #: 58
1992N-0489 Taxol; Enviromental Assessments and Fonsi
EA 5 TAXUS Express Paclitaxel-Eluting Coronary Stent System Vol #: 16
1993N-0480A Health Claims for Antioxidant Vitamins & Cancer
MT 1 HFS-832 to Emord & Associates, PC Vol #: 1
1993N-0480C Health Claims for Dietary Fiber & CVD
MT 1 HFS-832 to Emord & Associates, PC Vol #: 1
1993N-0480F Health Claims for Dietary Fiber & Cancer
MT 1 HFS-832 to Emord & Associates, PC Vol #: 1
1995N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability
EMC 1272 No signature Vol #: 378
EMC 1273 D. Monnier Vol #: 378
EMC 1274 No signature Vol #: 378
EMC 1275 K. Quillen Vol #: 378
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 13230 Enzymatic Therapy Natural Medicines Vol #: 108
LET 13231 Pharmavite LLC Vol #: 108
LET 13232 PhytoPharmica Natural Medicines Vol #: 108
LET 13233 Enzymatic Therapy Natural Medicines Vol #: 108
LET 13234 Tronex Pharmaceuticals Industries Vol #: 108
LET 13235 Perrigo Company of South Carolina Vol #: 108
LET 13236 LifeSpan Nutrition Vol #: 108
LET 13237 VitalState Inc. Vol #: 108
LET 13238 Health Direct (HD Nutrition, Inc.) Vol #: 108
LET 13239 Body Wise International, Inc. Vol #: 108
LET 13240 Body Wise International, Inc. Vol #: 108
LET 13241 Body Wise International, inc. Vol #: 108
LET 13242 Body Wise International, Inc. Vol #: 108
LET 13243 Body Wise International, Inc. Vol #: 108
LET 13244 Enzynmatic Therapy Natural Medicines Vol #: 108
LET 13245 Enzymatic Therapy Natural Medicines Vol #: 108
LET 13246 Enzymatic Therapy Natural Medicines Vol #: 108
LET 13247 Enzymatic Therapy Natural Medicines Vol #: 108
LET 13248 Enzymatic Therapy Nautral Medicines Vol #: 108
LET 13249 Enzymatic Therapy Natural Medicines Vol #: 109
LET 13250 Enzymatic Therapy Natural Medicines Vol #: 108
LET 13251 Enzymatic Therapy Natural Medicines Vol #: 109
LET 13252 Enzymatic Therapy Natural Medicines Vol #: 109
LET 13253 Enzymatic Therapy Natural Medicines Vol #: 109
LET 13254 Enzymatic Therapy Natural Medicines Vol #: 109
LET 13255 Planetary Formulas Vol #: 109
LET 13256 LaneLabs USA, Inc. Vol #: 109
LET 13257 Natrol, Inc. Vol #: 109
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
EMC 4180 S. Wolf Vol #: 515
1999P-2630 Establish a Daily Value for "added sugars"
EMC 765 S. Rodrick Vol #: 33
2000P-1322 Food Labeling and Allergen Contamination Control
EMC 537 L. Harris Vol #: 20
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 4304 J. Burghardt Vol #: 168
EMC 4305 B. Morse Vol #: 168
EMC 4306 S. Moses Vol #: 168
EMC 4307 B. Starr-Langhus Vol #: 168
EMC 4308 K. M. Kelly Vol #: 168
EMC 4309 E. Kenepp Vol #: 168
EMC 4310 J. Clagett Vol #: 168
EMC 4311 J. Stucker Vol #: 168
EMC 4312 R. & S. Silk Vol #: 168
EMC 4313 G. Kettas Vol #: 168
EMC 4314 J. E. Dudley-Ruel Vol #: 168
EMC 4315 L. Warren Vol #: 168
EMC 4316 L. Latham Vol #: 168
EMC 4317 A. St. Rose Vol #: 168
EMC 4318 L. Garcia Vol #: 168
EMC 4319 R. Garner Vol #: 168
EMC 4320 J. Prater Vol #: 168
EMC 4321 A. Auburn Vol #: 168
EMC 4322 W. Gerbereux Vol #: 168
EMC 4323 R. Guilfoyle Vol #: 168
EMC 4324 M.Cahn Vol #: 168
EMC 4325 G. Reese Vol #: 168
EMC 4326 L & I Berman Vol #: 168
EMC 4327 L. Danz Vol #: 168
EMC 4328 R. Jensen Vol #: 168
EMC 4329 J. Zablow Vol #: 168
EMC 4330 W. Hall Vol #: 168
EMC 4331 E. Gaustad Vol #: 168
EMC 4332 P. Gregory Vol #: 168
EMC 4333 G. Loehr Vol #: 168
EMC 4334 R. M. Laffoon Vol #: 168
EMC 4335 J. Beaver Vol #: 168
EMC 4336 C. Summerville Vol #: 168
EMC 4337 C. Summerville Vol #: 168
EMC 4338 R. M. Burns Vol #: 168
EMC 4339 R. L. Smith Vol #: 168
EMC 4340 P. S. Tynes Vol #: 168
EMC 4341 R. Saxton Vol #: 168
EMC 4342 J. Milliorn Vol #: 168
EMC 4343 Nick D. Vol #: 168
EMC 4344 G. Collins Vol #: 168
EMC 4345 J. Teall Vol #: 168
EMC 4346 J. Koppenhoefer Vol #: 168
EMC 4347 K. Poirier Vol #: 168
EMC 4348 J. P. Cessaro Vol #: 168
EMC 4349 C. Novak-Rainer Vol #: 168
EMC 4350 B. Hoke Vol #: 168
EMC 4351 l. D. Vol #: 168
EMC 4352 M. Gregory Vol #: 168
EMC 4353 P. Samuelson Vol #: 168
EMC 4354 J. H. Berry Vol #: 168
EMC 4355 N. Zurcher Vol #: 168
EMC 4356 R. Plum Vol #: 168
EMC 4357 D. SanMiguel Vol #: 168
EMC 4358 G. Lambert Vol #: 168
EMC 4359 J. Norton Jr. Vol #: 168
EMC 4360 E. Feder Vol #: 168
EMC 4361 A Poston Vol #: 168
EMC 4362 D. Honish Vol #: 168
EMC 4363 N. Pearson Vol #: 168
EMC 4364 S. Scott Vol #: 168
EMC 4365 H. chapin Vol #: 168
EMC 4366 K. Barthold Vol #: 168
EMC 4367 T. Hoekstra Vol #: 168
EMC 4368 Dr. J. F. Gay Vol #: 168
EMC 4369 S. Dietz Vol #: 168
EMC 4370 B. Bogiani Vol #: 168
EMC 4371 R. Koepsell Vol #: 168
EMC 4372 S. Dale Vol #: 168
EMC 4373 M. Vonn Vol #: 168
EMC 4374 V. P. Neumann Vol #: 168
EMC 4375 F. W. Vol #: 168
EMC 4376 C .Beard Vol #: 168
EMC 4377 A. Gallego Vol #: 168
EMC 4378 M. Granton Vol #: 168
EMC 4379 D. E. Williams Vol #: 168
EMC 4380 J. Schreiber Vol #: 168
EMC 4381 N. Sofranko Vol #: 168
EMC 4382 C. Holzle Vol #: 168
EMC 4383 G. Adrian Vol #: 168
EMC 4384 G. Szostak Vol #: 168
EMC 4385 C. Weed Vol #: 168
EMC 4386 P. M.Eggleston Vol #: 168
EMC 4387 J. Lukas Vol #: 168
EMC 4388 B. Campbell Vol #: 168
EMC 4389 D. Moodie Vol #: 168
EMC 4390 J. D. Alcantara Vol #: 168
EMC 4391 S. Rickert Vol #: 168
EMC 4392 R. Hickey Vol #: 168
EMC 4393 E. Black Vol #: 168
EMC 4394 S. Wilpan Vol #: 168
EMC 4395 B. Thompson Vol #: 168
EMC 4396 P. Harcarik Vol #: 168
EMC 4397 A. Patton Vol #: 168
EMC 4398 D. Dvorak Vol #: 168
EMC 4399 C. Stuart Vol #: 168
EMC 4400 T. Shields Vol #: 168
EMC 4401 M. Westlake Vol #: 168
EMC 4402 L. G. Henson Vol #: 168
EMC 4403 J. P. Bell Vol #: 168
EMC 4404 J. Buerge Vol #: 168
EMC 4405 E. H. Atkins Vol #: 168
EMC 4406 J. R. Charlton Vol #: 168
EMC 4407 B. Schuler Vol #: 168
EMC 4408 J. Cahill Vol #: 168
EMC 4409 C. Boyington Vol #: 168
EMC 4410 M. Free-Phelps Vol #: 168
EMC 4411 P. Rauch Vol #: 168
EMC 4412 C. Davis Vol #: 168
EMC 4413 T. Portney Vol #: 168
EMC 4414 C. N. Lynd Vol #: 168
EMC 4415 V. LaBruna Vol #: 168
EMC 4416 A. T. Yarrow Vol #: 168
EMC 4417 K. Kenyon Vol #: 168
EMC 4418 M. May Vol #: 168
EMC 4419 L. G. Goble Vol #: 168
EMC 4420 P. Conroy Vol #: 168
EMC 4421 L. Wood Vol #: 168
EMC 4422 J. Mulazzi Vol #: 168
EMC 4423 B. Salzman Vol #: 168
EMC 4424 C. O. Vol #: 168
EMC 4425 N. Garver Vol #: 168
EMC 4426 J. Stock Vol #: 168
EMC 4427 B. A. Zalesky Vol #: 168
EMC 4428 J. A. Latham Vol #: 168
EMC 4429 J. Wolfe Vol #: 168
EMC 4430 L. Bissell, M. D. Vol #: 168
EMC 4431 M. Jones Vol #: 168
EMC 4432 G. Jaeb Vol #: 168
EMC 4433 L. Larsen Vol #: 168
EMC 4434 K. Sutherland Vol #: 168
EMC 4435 C. Cline Vol #: 168
EMC 4436 E. Conner Vol #: 168
EMC 4437 R. Paro Vol #: 168
EMC 4438 G. Mateyake Vol #: 168
EMC 4439 M. Cherry Vol #: 168
EMC 4440 S. Newton Vol #: 168
EMC 4441 A. S. Abbasse Vol #: 168
EMC 4442 R. Lemay Vol #: 168
EMC 4443 J. Henriques Vol #: 168
EMC 4444 B. Constance Vol #: 168
EMC 4445 J. Riddell Vol #: 168
EMC 4446 B. Dufford Vol #: 168
EMC 4447 K. F. Johnson Vol #: 168
EMC 4448 S. Smith Vol #: 168
EMC 4449 E. Wilson Vol #: 168
EMC 4450 K. OConnor Vol #: 168
EMC 4451 N. Hetherington Vol #: 168
EMC 4452 T. Cunningham Vol #: 168
EMC 4453 J. Contreras Vol #: 168
EMC 4454 K. Marantz Vol #: 168
EMC 4455 A. Brumson Vol #: 168
EMC 4456 S. O. Allen Vol #: 168
EMC 4457 L. Blanchard Vol #: 168
EMC 4458 R. Johnson Vol #: 168
EMC 4459 M. E. Ford Vol #: 168
EMC 4460 J. Kring Vol #: 168
EMC 4461 D. Carver Vol #: 168
EMC 4462 I. Reich Vol #: 168
EMC 4463 S. Simpson Vol #: 168
EMC 4464 G. Childers Vol #: 168
EMC 4465 M. Schafrath Vol #: 168
EMC 4466 W. Willis Vol #: 168
EMC 4467 M. Kramer Vol #: 168
EMC 4468 C. Morrison Vol #: 168
EMC 4469 K. Marsik Vol #: 168
EMC 4470 D. Bartlett Vol #: 168
EMC 4471 S. & W. Chan Vol #: 168
EMC 4472 A. Lynn Vol #: 168
EMC 4473 C. Hansen Vol #: 168
EMC 4474 R. Dransield Vol #: 168
EMC 4475 R. Dransfield Vol #: 168
EMC 4476 J. Schneider Vol #: 168
EMC 4477 P. O'Malley Vol #: 168
EMC 4478 D. Martin Vol #: 168
EMC 4479 J. Jaffe Vol #: 168
EMC 4480 S. Stone Vol #: 168
EMC 4481 J. Volpe Vol #: 168
EMC 4482 K Shaub Vol #: 168
EMC 4483 J. Kimzey Vol #: 168
EMC 4484 M. Goss Vol #: 168
EMC 4485 R. West Vol #: 168
EMC 4486 J. Stanley-Dunham Vol #: 168
EMC 4487 Y. Brunot Vol #: 168
EMC 4488 M. Cooley Vol #: 168
EMC 4489 S. Berlincourt Vol #: 168
EMC 4490 C. Bolten Vol #: 168
EMC 4491 R. Zur Vol #: 168
EMC 4492 T. Burns Vol #: 168
EMC 4493 D. Di Gioia Vol #: 168
EMC 4494 J. Berger Vol #: 168
EMC 4495 J. Burch Vol #: 168
EMC 4496 P. Martin Vol #: 168
EMC 4497 G. Lopez Vol #: 168
EMC 4498 J. Galloway Vol #: 168
EMC 4499 T. Rumbo Vol #: 168
EMC 4500 M. F. Richardson Vol #: 168
EMC 4501 D. Van Horn Vol #: 169
EMC 4502 C. Kapps Vol #: 169
EMC 4503 K. S. Lynn Vol #: 169
EMC 4504 A. Bayer Vol #: 169
EMC 4505 S. Crane Vol #: 169
EMC 4506 K. Rohmier Vol #: 169
EMC 4507 J. Staples Vol #: 169
EMC 4508 W. Bakes Vol #: 169
EMC 4509 C. Janson M. D. Vol #: 169
EMC 4510 V. Ramos Vol #: 169
EMC 4511 N. McPhee Vol #: 169
EMC 4512 A. VanDercar Vol #: 169
EMC 4513 J. Latchney Vol #: 169
EMC 4514 E. Adler Vol #: 169
EMC 4515 N. Iannuzzelli Vol #: 169
EMC 4516 J. Jones Vol #: 169
EMC 4517 S. Yazodpour Vol #: 169
EMC 4518 J. Gibson Vol #: 169
EMC 4519 D. Riley Vol #: 169
EMC 4520 P. R. Johnson Vol #: 169
EMC 4521 J. Bade Vol #: 169
EMC 4522 P. Dailey Vol #: 169
EMC 4523 K. Bennett Vol #: 169
EMC 4524 M. D. Eager Vol #: 169
EMC 4525 J. Scanlon Vol #: 169
EMC 4526 A. Dollyhigh Vol #: 169
EMC 4527 S. Ramsey Vol #: 169
EMC 4528 C. Fox Vol #: 169
EMC 4529 T. P. Foley Vol #: 169
EMC 4530 P. Casazza Vol #: 169
EMC 4531 L Demarco Vol #: 169
EMC 4532 D. Roth, M.D. Vol #: 169
2002N-0204 Bar Code Label Requirements for human drug products
NAL 1 FDA Vol #: 15
SS 1 Supporting Statement Vol #: 15
2002N-0417 Applications for FDA Approval to Market a New Drug
NFR 2 FDA Vol #: 4
2003D-0493 Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
EMC 8 Merck & Co., Inc. (Merck) Vol #: 2
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 144 K. Scarborough Vol #: 3
2003N-0496 Food Labeling: Health Claims; Dietary Guidance
EMC 15 Nestle USA Vol #: 7

Page created on March 16, 2004 dp
Page updated on March 22, 2004 jb

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